Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086562
Company: ORGANON USA INC
Company: ORGANON USA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| WIGRAINE | CAFFEINE; ERGOTAMINE TARTRATE | 100MG;1MG | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/05/1980 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/02/2000 | SUPPL-17 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 10/14/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/21/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/07/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/31/1993 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 08/31/1993 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 03/07/1994 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/12/1998 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 01/19/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/06/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/14/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/29/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/29/1983 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |